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Study identifier: NCT07059728 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

High Flow Nasal Oxygenation in Transcatheter Aortic Valve Replacement Procedures. TAVR-Highflow II

Condition: Aortic Stenosis Treated With TAVI · Sedation; Aged; Hemodynamics  ·  Sponsor: Hospital Clinic of Barcelona

PhaseNA
Planned participants452
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with aortic valve disease. TAVR is a less invasive treatment compared to the conventional surgical approach through median sternotomy. Patients selected for this procedure often have a profile associated with multiple comorbidities which predispose them to certain complications. TAVI procedures were initially performed under general anesthesia. However, due to improved procedure times and anesthetic techniques, sedation has become the current trend to preform them. When sedation for these procedures requires deep planes, hypoxia is more likely to occur due to respiratory depression, apnea, or airway obstruction. This is even more common in TAVR patients population, as obesity, sleep apnea, elevated ASA classification, advanced age, and combined cardiorespiratory disease are highly prevalent. For all these reasons, TAVR constitutes a risky procedure, presenting a profile of patients undergoing this procedure that can also be considered high risk. The provision of supplemental oxygen through nasal cannulae or face masks can prevent the development of hypoxia. Unfortunately, non-humidified nasal oxygen cannot exceed 2-5 L/min without causing damage to the nasal mucosa, and the percentage of oxygen delivered through variable-flow face masks is unpredictable. On the other hand, high-flow nasal oxygen therapy (HFNO) can provide humidified gas flow rates of up to 70 L/min through special…

This description comes directly from the study's public registry record.

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Locations (1)

Hospital Clinic de BarcelonaBarcelona, Barcelona, SpainRecruiting

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Source record: clinicaltrials.gov/study/NCT07059728